Gastroesophageal Reflux Disease
Conditions
Keywords
Gastroesophageal Reflux Disease, Retrospective Cohort, Surgical Treatment, Real-World Data, Quality of Life
Brief summary
This retrospective, observational cohort study aimed to establish a comprehensive research cohort utilizing a large-scale prospective clinical registry. The primary objectives were to characterize the real-world demographic profiles, clinical features, psychological characteristics, and treatment patterns of Chinese patients with gastroesophageal reflux disease (GERD), as well as to evaluate post-treatment improvements in both GERD symptoms and psychological well-being. The study retrospectively enrolled approximately 5,000 patients with a confirmed diagnosis of GERD, with data derived from the prospective registry of the National Clinical Research Center for Digestive Diseases. Investigators systematically extracted data on baseline demographics, clinical presentations, objective diagnostic findings, preoperative psychological status, surgical complications, and longitudinal follow-up outcomes for all eligible patients. Ultimately, this study sought to provide high-quality, China-specific evidence to inform the precise phenotyping of GERD and to guide standardized, individualized clinical decision-making.
Interventions
Data on clinical symptoms, treatment details, and long-term follow-up outcomes were retrospectively extracted from electronic medical records (EMRs) and institutional databases.
Sponsors
Beijing Friendship Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 18 and 90 years old. * Patients were required to present with at least one typical symptom of gastroesophageal reflux disease (GERD)-such as heartburn, regurgitation, or non-cardiac chest pain-and to have presented to Beijing Friendship Hospital for the evaluation and management of these symptoms. * Received treatment, including pharmacological therapy and anti-reflux surgery, at Beijing Friendship Hospital. * Voluntary signing of informed consent, agreeing to the use of clinical information for future research.
Exclusion criteria
* Female patients who were pregnant or lactating. * Patients with significantly incomplete or missing critical clinical data. * Patients with an equivocal or unconfirmed diagnosis of GERD. * Current neurologic or cognitive impairment, which would preclude ability to obtain informed consent. * Refusal to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pre- and Post-Treatment Improvement in GERD-HRQL Scores | From pre-treatment to up to 10 years post-treatment | The Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) questionnaire is utilized to assess patient outcomes as a quantitative variable. The scale comprises 11 items, each scored from 0 to 5, with higher scores indicating a better quality of life (QoL). Clinical success is defined as a \>50% reduction in the total symptom score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pre- and Post-Treatment Improvement in GERD-Q Scores | From pre-treatment to up to 10 years post-treatment | The Gastroesophageal Reflux Disease Questionnaire (GERD-Q) is utilized to evaluate GERD symptoms. The total score ranges from 0 to 18, with higher scores indicating greater symptom severity. |
| Pre- and Post-Treatment Improvement in GSAS Scores | From pre-treatment to up to 10 years post-treatment | The GERD Symptom Assessment Scale (GSAS) is employed to evaluate GERD symptoms. The total score ranges from 0 to 45, with higher scores indicating greater symptom severity. |
| Pre- and Post-Treatment Improvement in GIQLI Scores | From pre-treatment to up to 10 years post-treatment | The Gastrointestinal Quality of Life Index (GIQLI) is utilized to assess quality of life in patients with gastrointestinal diseases. It comprises five subscales with a total score ranging from 0 to 144. Higher scores indicate a better quality of life and superior therapeutic efficacy. |
| Pre- and Post-Treatment Improvement in EHAS Scores | From pre-treatment to up to 10 years post-treatment | The Esophageal Hypervigilance and Anxiety Scale (EHAS) is utilized to assess esophageal-specific hypervigilance and anxiety. It comprises two subscales with a total score ranging from 0 to 56, with higher scores indicating more severe esophageal hypervigilance and anxiety. |
| Pre- and Post-Treatment Improvement in HADS Scores | From pre-treatment to up to 10 years post-treatment | The Hospital Anxiety and Depression Scale (HADS) is employed to evaluate patient anxiety and depression. It comprises two subscales with a total score ranging from 0 to 42, with higher scores indicating more severe states of anxiety and depression. |
| Esophagitis Severity | From pre-treatment to up to 10 years post-treatment | Evaluated via gastroscopy according to the Los Angeles (LA) classification. |
| Severity of Hiatal Hernia | From pre-treatment to up to 10 years post-treatment | Evaluated via gastroscopy according to the Hill classification. |
| Presence of Barrett's Esophagus | From pre-treatment to up to 10 years post-treatment | Evaluated via gastroscopy. |
| Acid Exposure Time (AET) | From pre-treatment to up to 10 years post-treatment | Quantified via pH-impedance monitoring. AET serves as the primary and most reliable metric for diagnosing objective GERD and evaluating the true burden of acid reflux, \>4% indicate abnormal acid reflux |
| Number of Reflux Episodes | From pre-treatment to up to 10 years post-treatment | Quantified via pH-impedance monitoring. |
| DeMeester Score | From pre-treatment to up to 10 years post-treatment | The DeMeester Composite Score quantifies the severity of Gastroesophageal Reflux Disease (GERD). It is calculated from 24-hour ambulatory esophageal pH monitoring using six acid exposure parameters: percentage of total, upright, and supine time with pH \< 4; total reflux episodes; episodes lasting \> 5 minutes; and the duration of the longest episode. Each parameter is scored using the formula SV = (X - A) / SD + 1, where X is the measured value, A is the healthy baseline mean, and SD is the baseline standard deviation. The total score is the sum of these six values. Minimum value: 0. Maximum value: No fixed upper limit (unbounded). In clinical applications, higher scores indicate more severe pathological acid exposure. |
| Symptom Index (SI) | From pre-treatment to up to 10 years post-treatment | Derived from pH-impedance monitoring to determine the temporal correlation between symptom events and reflux episodes, confirming whether a patient's symptoms are specifically reflux-driven. An SI of ≥ 50% is universally considered positive, indicating a clinically meaningful symptom-reflux association. |
| Symptom Reflux Index (SRI) | From pre-treatment to up to 10 years post-treatment | Derived from pH-impedance monitoring to provide statistical validation of the symptom-reflux association, which is crucial for accurately phenotyping functional versus organic GERD. An SRI of ≥ 95% (often utilized interchangeably with Symptom Association Probability, SAP) is considered positive, providing strong statistical evidence that symptoms are not occurring by chance. |
| Esophagogastric Junction (EGJ) Expiratory Pressure | From pre-treatment to up to 10 years post-treatment | Measured via high-resolution manometry (HRM). |
| Integrated Relaxation Pressure (IRP) | From pre-treatment to up to 10 years post-treatment | Measured via high-resolution manometry (HRM). |
| Esophagogastric Junction (EGJ) Morphology | From pre-treatment to up to 10 years post-treatment | Evaluated via high-resolution manometry (HRM) to assess hiatal hernia status. |
| Distal Latency (DL) | From pre-treatment to up to 10 years post-treatment | Measured via high-resolution manometry (HRM). |
| Distal Contractile Integral (DCI) | From pre-treatment to up to 10 years post-treatment | Measured via high-resolution manometry (HRM). |
| Esophageal Motility Type | From pre-treatment to up to 10 years post-treatment | Evaluated via high-resolution manometry (HRM) according to the Chicago classification. |
| Hiatal Hernia Size | From pre-treatment to up to 10 years post-treatment | Evaluated via computed tomography (CT). |
| Helicobacter pylori Infection Status | From 30 days prior to surgery to 10 years post-surgery | Helicobacter pylori infection status determined by ¹³C/¹⁴C urea breath test. |
| Acid-Suppressive Medication Regimen | From enrollment to the end of treatment, assessed up to 12 weeks | This encompasses the specific medication name, prescribed dosage, and administration frequency. |
| Operation Time | At the time of surgery | — |
| Blood Loss | At the time of surgery | — |
| Abdominal Drainage Fluid Volume | From treatment to 30 days after surgery | — |
| Total Duration of Hospitalization | From treatment to 30 days after surgery | — |
| Incidence of Postoperative Complications | From treatment to 30 days after surgery | — |
Countries
China
Contacts
CONTACTZhi Zheng, Attending surgon
Outcome results
None listed